Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

NTDDI CALLS FOR BRAZIL TO DROP TARIFFS ON ESSENTIAL DRUGS

Brazil's average tariffs on essential drugs and medical devices are 38%, among
the highest in the world, according to a recent study by the No Taxes on Drugs
and Devices Initiative (NtDDi). The body is calling for the country to drop
taxes and tariffs on all life-saving medicines to improve access for the country's
population.

However, the Brazilian government is worried that such a move will endanger
local drug production. There are currently some 550 pharmaceutical companies
in Brazil, employing around 23,000 people and accounting for 90% of domestic
consumption.

The World Trade Organisation (WTO) has criticised this stance, claiming that
strict tariff regimes endanger lives. Foreign drugmakers claim that Brazil is
displaying double standards. After all, the government demanded Abbott Laboratories
reduce its price for HIV/AIDS treatment Kaletra, claiming that lives were at
risk, yet it supports prohibitive tariffs for a number of treatments for chronic
diseases. The NtDDi estimates that a 1% drop in tariffs and taxes would increase
access to essential drugs by 1%.